Fla. Admin. Code Ann. R. 64B16-30.002 - Minor Violations

(1) The Board sets forth the following guidelines for use by Department investigators when a licensee is in noncompliance of an initial offense of a minor violation. The Board deems the following violations, depending upon severity, to be consistent with section 456.073(3), F.S.

(a) Outdated pharmaceuticals - rule 64B16-28.110, F.A.C.

(b) Failure to meet regulation of daily operating hours - rule 64B16-28.404, F.A.C.

(c) Generic substitution sign not displayed - section 465.025(7), F.S.

(d) Information required on controlled substance prescriptions: practitioner's address, practitioner's DEA registration number, patient's address - section 893.04, F.S.

(e) Failure to have certified by dispensing pharmacists the daily hard-copy printout or daily log - paragraph 64B16-28.140(3)(c) or (e), F.A.C.

(f) Failure to have pharmacy minimally equipped i.e. references, compounding equipment, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida - rule 64B16-28.107, F.A.C.

(g) Failure to properly identify pharmacy technicians - rule 64B16-27.410, F.A.C.

(h) Results of P&E quality assurance program not documented or available for inspection - paragraph 64B16-28.820(3)(d), F.A.C.

(i) Improper storage of legend drugs - rule 64B16-28.120, F.A.C.

(j) Improper documentation of destruction of controlled substances - rules 64B16-28.301, 64B16-28.303, F.A.C.

(k) Consultant pharmacist's monthly reports not current or available for inspection - rule 64B16-28.501, subsection 64B16-28.702(2), F.A.C.

(l) Controlled substance prescription labels lack transfer crime warning labeling - paragraph 64B16-28.502(2)(c), F.A.C.

(m) Failure to maintain proof of licensure, display licenses/registrations or notices, or to properly identify pharmacy staff - rule 64B16-27.100, F.A.C.

(n) Failure to have a continuously designated Prescription Department Manager or Consultant Pharamcist of Record, if the gap between designations is less than fifteen (15) business days - rules 64B16-27.450 and 64B16-28.501, F.A.C.

(2) The Department's investigator may issue a Notice of Deficiencies when the above conditions occur and the requirements of section 456.073(3), F.S., are met. In such cases licensees shall correct the violation and respond to the investigator on forms provided by the Department and with other evidence of compliance as may be necessary, within 30 days, to certify current compliance. Failure to do so shall subject the licensee to further proceedings.

Notes

Fla. Admin. Code Ann. R. 64B16-30.002

Rulemaking Authority 456.073(3), 465.005 FS. Law Implemented 456.073(3) FS.

New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002, Amended 12-9-98, 8-26-02, Amended by Florida Register Volume 43, Number 206, October 24, 2017 effective 11/7/2017, Amended by Florida Register Volume 44, Number 124, June 26, 2018 effective 7/11/2018.

New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002, Amended 12-9-98, 8-26-02, 11-7-17, 7-11-18.